EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort
study of new users of drospirenone/ethinylestradiol (DRSP/EE),
levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine
conditions of medical practice in seven European countries. Baseline survey and semiannual,
active follow-up are based on postal questionnaires, with validation of reported events by
the women's treating physicians. A multifaceted 4-level follow-up procedure will be
established to ensure low loss to follow-up rates. The objective of the study is the
investigation of the incidence of rare serious adverse events associated with the use of new
and established OCs, and specifically the incidence of thromboembolic events.
Details
Lead Sponsor:
Center for Epidemiology and Health Research, Germany